Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020729
Company: UCB INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
UNIRETIC HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
UNIRETIC HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
UNIRETIC HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/27/1997 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/13/2012 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020729s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020729Orig1s026ltr.pdf
01/19/2012 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020729s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020312s034,020729s025ltr.pdf
08/23/2011 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020729s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020729s024ltr.pdf
05/19/2011 SUPPL-23 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020729s023lbl.pdf
01/13/2010 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020729s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020729s021ltr.pdf
10/29/2003 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20312slr012,20312slr024ltr.pdf
02/14/2002 SUPPL-10 Manufacturing (CMC)-Formulation Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20729s10ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020729_S010_UNIRETIC.pdf
09/24/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

12/22/2000 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/12/2001 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/10/2000 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/05/2000 SUPPL-5 Labeling

Label is not available on this site.

10/29/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/22/1999 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/21/1998 SUPPL-2 Labeling

Label is not available on this site.

11/18/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/13/2012 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020729s026lbl.pdf
01/19/2012 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020729s025lbl.pdf
08/23/2011 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020729s024lbl.pdf
05/19/2011 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020729s023lbl.pdf
01/13/2010 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020729s021lbl.pdf

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